Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination
Use of a Pocket-sized Ultrasound Device as an Aid to the Physical Examination for Internal Medicine Residents
The 40 resident study subjects will be randomized to either receive a training session on
use of a pocket-sized ultrasound or to receive training on physical exam skills. Following
these sessions the subjects will have the opportunity to practice their skills during
clinical rounds at BWH inpatient and outpatient settings. Four weeks after the training
session all study subjects will take part in an assessment of their diagnostic skills.
During this assessment they will be asked to complete an exam on a patient subject. Those
randomized to the ultrasound group will be allowed to use their devices while the control
group will use the traditional physical exam. Following the exams, resident study subjects
will be asked to indicate whether they detected any of the following abnormalities on their
exams: pleural effusion, hepatomegaly, cirrhotic liver, splenomegaly, ascites, aortic
stenosis, mitral regurgitation, right atrial pressure, abdominal aortic aneurysm, deep vein
thrombosis. Resident study subjects will also complete a questionnaire about the physical
exam and use of the ultrasound. Prior to the assessment, all patients will undergo
ultrasound by an attending radiologist, and these results will serve as the "gold standard"
for our study.
II. Specific Aims:
Study population: Internal medicine residents at an academic center
Patient population: A broad population of patients with diverse clinical conditions
including cardiac and vascular disease, malignancy, rheumatologic disease, liver disease,
renal failure, and others. This population will reflect the diversity of patients seen by
internal medicine residents during their training.
Physical findings being studied:
1. Abdominal: hepatomegaly, cirrhotic liver, splenomegaly, ascites, abdominal aortic
2. Lungs: pleural effusion, pneumothorax, paralyzed hemidiaphragm.
3. Cardiac: pericardial effusion, mitral regurgitation, tricuspid regurgitation, aortic
insufficiency, aortic stenosis, right atrial pressure.
Determine the diagnostic accuracy of residents using a pocket-sized ultrasound device
compared with residents using more traditional physical exam techniques for the physical
findings mentioned above.
- Determine whether medicine residents improve their physical exam diagnostic skills
after receiving training with pocket-sized ultrasound devices.
- Determine the additional diagnostic benefit of pocket-sized ultrasound versus a
traditional physical exam.
- Assess the diagnostic physical exam skills of medicine residents as compared with
- Assess the diagnostic ultrasound skills of medicine residents as compared with trained
radiologists using pocket-sized ultrasounds.
- Assess the degree of agreement between expert physical diagnosticians and trained
radiologists using pocket-sized ultrasound.
- Evaluate the ability of residents to integrate ultrasound examination into their daily
patient care routines
III. Subject Selection:
All interns and residents in the BWH internal medicine residency program who responded to a
recruitment email and agreed to participate.
- Radiology Preliminary residents
- Residents with previous formalized ultrasound training that included a practical
Resident Recruitment Methods:
All interns and residents in the BWH internal medicine residency program will be invited to
participate in the study. The study will be advertised via email and announcements at
residency educational conferences. Because Dr. Katz and Dr. Yialamas are part of the BWH
residency leadership, they will not participate in the recruitment of residents to avoid a
potential undue pressure to participate.
Patient Recruitment Methods:
Advertisements will be sent to selected faculty within the departments of medicine and
radiology with details of patient involvement and the selected physical findings which will
be studied. Patients will be asked by their treating physician or radiologist involved in
their care if they can be contacted by the study coordinator. The coordinator will then
assess interest and availability. Patients will then be consented if they agree to
participate. Fourteen patient-subjects will ultimately be selected to participate in our
assessment program. They will be compensated $350 for participating.
IV. Subject Enrollment
Forty of the residents who responded to the email advertisement will be randomly selected to
be enrolled. Each resident enrolled will be consented by one of the investigators prior to
participating in the study. The verbal consent process will assure subjects that study data
and results will not appear in their residency record, or be used in any way by the
residency program. They will therefore remain wholly within the purview of the investigation
staff, and will not form any part of their residency evaluation. Each of the forty residents
who participates in our study will receive a compensation of $150 for their time.
V. Study Procedures
Randomization and Curricular Training The 40 participating residents will be randomized to
either the control or intervention group by having them blindly pick small pieces of paper
with numbers out of a paper bag. All residents will participate in a 2 hour physical exam
education session led by senior internal medicine faculty. Those randomized to the
ultrasound group will also attend a 2 hour pocket-ultrasound training session which will be
run by a BWH faculty radiologist and a BWH faculty echocardiographer. Following this
training session, each of the 20 residents will be given a pocket-sized ultrasound device
which they will be able to use as an adjunct to their physical exam while in clinic or on
inpatient wards. Because the resident physicians are not trained ultrasound radiologists,
these ultrasound studies will be informal and the results will not become part of any
patient's medical record. Participants in the control arm of the study will not receive
pocket-sized ultrasound devices nor will they receive training on how to use the machines.
Physical Exam Assessment Session Four weeks after randomization, all 40 of the resident
subjects will attend a half-day physical exam assessment. This assessment will take place in
the Brigham Circle Medical Associates Clinic on the Third Floor of the BWH Shapiro
Cardiovascular Building. The assessment will also include the participation of 14 patient
subjects who will be recruited ahead of time.
At the start of the day, each of the 14 patient subjects will be examined by two senior
internal medicine clinicians to determine the presence of the physical exam findings being
studied. Each patient subject will also undergo ultrasound evaluation by two BWH
radiologists or echocardiographers to radiographically confirm the presence of the
abovementioned physical findings. The "gold standard" for this study will be clinically
detectable physical findings (as confirmed by senior clinicians) that are also confirmed by
an ultrasound study performed by a radiologist or echocardiographer.
Patient study subjects will each be assigned to a clinic room and study subjects will rotate
through each of the 14 rooms over the course of the half-day session. Each interaction will
last 5 minutes and will consist of a focused physical examination of the patient. All 40
medicine residents will perform a routine physical exam on each patient and will document
their findings. The 20 residents in the intervention group will also perform an exam on the
same patients using a pocket-sized ultrasound and will document their findings.
Following the assessment, those study subjects randomized to the control group will have the
opportunity to participate in a brief ultrasound training session, and they will also have a
chance to practice using the ultrasounds during clinical practice over the following week.
VI. Biostatistical Analysis
Data collected during the assessment will include both binary variables for the presence of
the aforementioned physical exam findings as well as to categorize the severity of each
finding (mild, moderate, severe). Clinical definitions for these categories will be defined
ahead of time. In addition, a short questionnaire will be distributed to all of the subjects
and patient study subjects. The questionnaire will ask subjects about their comfort in
performing various aspects of the physical exam, their use of handheld ultrasound devices,
as well as their experiences teaching medical students and residents the physical exam.
Patient study subjects will answer a questionnaire about their attitude towards being
examined by a physician using a handheld ultrasound device.
Primary outcome measure: Physical exam diagnostic accuracy of residents compared with the
diagnostic accuracy of residents using pocket-sized ultrasound devices.
Secondary outcome measures:
1. For the sub-group of residents with pocket-sized ultrasounds: comparing the diagnostic
accuracy of routine physical exam versus with the ultrasound (i.e. how much additional
diagnostic yield did the ultrasound provide?).
2. Comparing the diagnostic accuracy of physical exams by medical residents with the exams
performed by the expert clinicians.
3. Comparing the diagnostic accuracy of pocket-sized ultrasounds performed by medical
residents with the studies performed by expert radiologists and echocardiographers.
4. Assess the degree of agreement between expert physical diagnosticians and trained
radiologists using pocket-sized ultrasound.
VII. Risks and Discomforts
We see no potential for harm to either study subjects or patient study subjects in this
study. Ultrasound is a safe modality that does not involve ionizing radiation. We do not
anticipate any pain or discomfort to our patient study subjects.
If any previously-unknown abnormalities are noted by our faculty radiologists or study
subjects while performing an ultrasound on patient study subjects, the patient's primary
care physician will be notified.
VIII. Potential Benefits The benefits of our study for participants will be the satisfaction
of participating in a research study that has the potential to ultimately improve patient
We believe the potential global benefits from our study are significant. If handheld
ultrasound devices prove to be helpful to internal medical residents in their physical
assessment of patients, we would recommend that these machines be made available through the
residency program. We hypothesize that handheld ultrasounds will enable internists to
augment their physical exam skills with a direct impact on improving patient care.
IX. Monitoring and Quality Assurance
Because our study does not involve any potential harm to participants we do not anticipate
the need for an independent safety monitoring board. All participants will, however, be
encouraged to report any possible adverse events to our study coordinator, and participants
will have the option of withdrawing from the study at any time.
Splenomegaly, Pleural Effusion
splenomegaly, pleural effusion
Brigham and Women's Hospital
Brigham and Women's Hospital, General Electric